Endovascular stent graft system and guide system

Abstract

Apparatus and method for inserting a stent graft limb branch into a stent graft body disposed in a living being, the stent graft body having a trunk and an opening for receiving said branch. A guide element is inserted through a vessel of the living being to the vicinity of the branch receiving opening of the stent graft body. The guide element is manipulated in three dimensions to form a shape corresponding to the orientation of the branch receiving opening with respect to the position of the vessel, so that the guide element shape is varied, in situ, to the required shape despite any abnormalities in the shape and orientation of the vessel. The guide element, after formation into the proper shape, is inserted into the branch receiving opening of the stent graft body. The stent graft limb branch is then fed over the guide element until the distal end of the limb branch is received in the branch receiving opening of the stent graft body. The guide element itself is also novel.

1 . A method of inserting a stent graft limb branch into a stent graft body disposed in a living being, said stent graft body having a trunk and an opening for receiving said branch, comprising:
 inserting a guide element through a vessel of the living being to the vicinity of the branch receiving opening of the stent graft body;   manipulating the guide element in three dimensions to form a shape corresponding to the orientation of the branch receiving opening with respect to the position of the vessel, whereby the guide element shape is varied, in situ, to the required shape despite any abnormalities in the shape and orientation of the vessel;   inserting the guide element, after formation into the proper shape, into the branch receiving opening of the stent graft body;   feeding the stent graft limb branch over the guide element until the distal end of the limb branch is received in the branch receiving opening of the stent graft body.   
     
     
         2 . The method as set forth in  claim 1  wherein the manipulating step includes forming the guide element into an up-going shape. 
     
     
         3 . The method as set forth in  claim 1  wherein the manipulating step includes forming the guide element into a down-going shape. 
     
     
         4 . The method as set forth in  claim 1  wherein the manipulating step includes forming the guide element into an out-of-plane shape. 
     
     
         5 . The method as set forth in  claim 4  wherein the manipulating step includes forming the guide element into a counter-clockwise out-of-plane shape. 
     
     
         6 . The method as set forth in  claim 4  wherein the manipulating step includes forming the guide element into a clockwise out-of-plane shape. 
     
     
         7 . The method as set forth in  claim 1  wherein the manipulating step includes forming the guide element into an up-going, out-of-plane shape. 
     
     
         8 . The method as set forth in  claim 1  wherein the manipulating step includes forming the guide element into a down-going, out-of-plane shape. 
     
     
         9 . The method as set forth in  claim 1  wherein the guide element includes first and second elements with distal end portions capable of assuming curves, said first and second elements being coaxially disposed and longitudinally movable with respect to each other. 
     
     
         10 . The method as set forth in  claim 1  wherein the guide element provides a stable platform for the feeding of the stent graft limb branch. 
     
     
         11 . The method as set forth in  claim 1  wherein the manipulating of the guide element occurs under fluoroscopic imaging. 
     
     
         12 . The method as set forth in  claim 1  wherein the manipulating for the guide element occurs under optical imaging. 
     
     
         13 . The method as set forth in  claim 1  wherein the stent graft body is disposed in an abdominal artery. 
     
     
         14 . The method as set forth in  claim 1  wherein the stent graft body is disposed in a suprarenal abdominal artery. 
     
     
         15 . The method as set forth in  claim 1  wherein the stent graft body is disposed in a thoracic artery. 
     
     
         16 . Apparatus for inserting a stent graft limb branch into a stent graft body disposed in a living being, said stent graft body having a trunk and an opening for receiving said branch, comprising:
 a guide element sized to pass through a vessel of the living being to the vicinity of the branch receiving opening of the stent graft body;   means for manipulating the guide element in three dimensions to form a shape corresponding to the orientation of the branch receiving opening with respect to the position of the vessel, whereby the guide element shape is varied, in situ, to the required shape despite any abnormalities in the shape and orientation of the vessel;   said the guide element, after formation into the proper shape, being of a size and shape to enter into the branch receiving opening of the stent graft body;   said stent graft limb branch being movable over the guide element until the distal end of the limb branch is received in the branch receiving opening of the stent graft body.   
     
     
         17 . The apparatus as set forth in  claim 16  wherein the guide element is a guide wire with a curved distal end portion and the means for manipulating includes a catheter with a distal end portion capable of assuming a curve such that the guide wire curved distal end portion and the catheter distal end portion interact to form the required three-dimensional shape. 
     
     
         18 . The apparatus as set forth in  claim 16  wherein the guide element is a straight guide wire and the means for manipulating includes a first catheter with a distal end portion capable of assuming a curve and a second catheter with a distal end portion capable of assuming a curve such that the distal end portions of the first and second catheters interact to form the required three-dimensional shape, the guide wire being extendible from the first and second catheters. 
     
     
         19 . A guide system for guiding medical tubes to sites in a living body, comprising:
 a guide element sized to pass through a vessel of the living being to the vicinity of the body at which a procedure is to be performed; and   means for manipulating the guide element in three dimensions to form a shape corresponding to the orientation of an operative area with respect to the position of the vessel, whereby the guide element shape is varied, in situ, to the required shape despite any abnormalities in the shape and orientation of the vessel.   
     
     
         20 . The apparatus as set forth in  claim 19  wherein the guide element is a guide wire with a curved distal end portion and the means for manipulating includes a catheter with a distal end portion capable of assuming a curve such that the guide wire curved distal end portion and the catheter distal end portion interact to form the required three-dimensional shape. 
     
     
         21 . The apparatus as set forth in  claim 19  wherein the guide element is a straight guide wire and the means for manipulating includes a first catheter with a distal end portion capable of assuming a curve and a second catheter with a distal end portion capable of assuming a curve such that the distal end portions of the first and second catheters interact to form the required three-dimensional shape, the guide wire being extendible from the first and second catheters.